Oral mouthpiece and method for the use thereof

ABSTRACT

The present invention relates generally to an oral device, or mouthpiece, for delivering a fluid to the mouth or oropharynx of a user. In one embodiment, the oral device includes an intraoral portion, an extraoral portion, and an auxiliary support device that serves to stabilize the oral device. In various embodiments, the auxiliary support device may be configured with ear loops, a support band, a support frame and/or a support member. The intraoral portion generally includes at least one outlet port through which the fluid is delivered to the oral cavity or oropharynx. A method of dispensing a fluid using the oral device is also provided.

This application is a continuation of U.S. application Ser. No.13/040,058, filed Mar. 3, 2011, which application claims the benefit ofU.S. Provisional Application No. 61/310,590, filed Mar. 4, 2010 andentitled Portable High Frequency Air Pulse Delivery Device, U.S.Provisional Application No. 61/311,145, filed Mar. 5, 2010 and entitledOral Mouthpiece and Method for Use Thereof, and U.S. ProvisionalApplication No. 61/417,041, filed Nov. 24, 2010 and entitled OralMouthpiece and Method for the Use Thereof, the entire disclosures ofwhich are hereby incorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to oral appliances and in particular a mouthpieceused to deliver at least one substance or stimulus.

BACKGROUND OF THE INVENTION

Swallowing is a complex behavior in which the output of an integrativebrainstem network gives rise to a patterned movement sequence describedas the pharyngeal stage of swallowing. While several lines of evidencehave demonstrated the importance of oropharyngeal sensory inputs inactivating this medullary swallowing network, the range of afferentpatterns that are both necessary and sufficient to evoke swallowing hasnot been fully elucidated. Stimulation of receptive fields innervated bythe superior laryngeal nerve (SLN) or the pharyngeal branch of theglossopharyngeal nerve (GPNph) appear to be particularly effective inevoking or modulating the pharyngeal swallow; these “reflexogenic” areascorrespond to the laryngeal mucosa, including the epiglottis andarytenoids, the lateral pharyngeal wall, posterior tonsillar pillar andperitonsillar areas.

In humans, the anterior faucial pillar historically has been consideredthe most reflexogenic site for swallowing. However, the recent findingthat the pharyngeal swallow may begin after the bolus head passes theanterior faucial pillars in healthy adults, including geriatric adults,suggests that stimulation of more posterior pharyngeal regions may helpfacilitate the initiation of swallowing. The importance of moreposterior oropharyngeal areas in swallowing elicitation is alsosuggested by anatomic evidence that the human posterior tonsillarpillar, as well as discrete regions of the palate, pharynx andepiglottis are innervated by a dense plexus formed from the GPNph andthe internal branch of the SLN. The spatial correspondence between theseareas of dual SLN/GPNph innervation and reflexogenic areas forswallowing has lead to the hypothesis that swallowing is elicited mostreadily by stimulation of areas innervated by both the GPNph and SLN.Dynamic stimuli that excite primary afferents within a number ofreceptive fields over time appear to elicit swallowing more readily thando static stimuli.

A variety of stimulus modalities have been applied in attempts to evokeswallowing (for review, see Miller, 1999). Repetitive electricalstimulation of the SLN or the GPN, particularly at stimulationfrequencies between 30 and 50 Hz, evokes swallowing in a number ofanimal species. This suggests that the repetitive nature of thestimulus, and the repetition rate, are critical variables in swallowingelicitation. More recently, electrical stimulation of the pharynx hasbeen reported to increase both the excitability and size of thepharyngeal motor cortex representation in humans (14), and facilitateswallowing in dysphagic patients following stroke. Mechanical andchemical stimuli can evoke swallowing in animal species. In humans,reports of the effects of cold mechanical stimulation of the anteriortonsillar pillar have been variable, some authors reporting decreases inswallowing latency and increases in swallowing frequency (16), andothers failing to find an effect of this type of stimulation onoropharyngeal bolus transit, esophageal coordination, or the temporalpattern of swallowing. Three studies have examined the effects of coldmechanical stimulation applied to the anterior tonsillar pillars insmall samples of dysphagic stroke patients. They reported a short-termfacilitation of swallowing, measured in terms of reduced delay of thepharyngeal swallow, in some patients, with no related reduction inaspiration. Longitudinal studies, examining the potential long-termeffects of oropharyngeal sensitisation on not only swallowing physiologybut also on nutritional and respiratory health, have not been reported.Reports on the effects of gustatory stimuli also have been variable. Asour bolus has been reported to facilitate swallowing in stroke. Whereassome authors have reported that swallowing latency is significantlyreduced by a combination of mechanical, cold, and gustatory (sour)stimulation, others have reported that a cold plus sour bolus reducesthe speed of swallowing.

Air-pulse trains also have been considered as a stimulus that mayfaciliate the pharyngeal swallow. For example, a single air pulse is adynamic stimulus that could be applied to a number of receptive fieldsincluding regions innervated by both the GPNph and SLN. Furthermore, anair-pulse train represents a repetitive stimulus that can be applied atspecific frequencies and pressures. Some devices have been suggested fordelivering such air-pulse trains, as disclosed for example in US patentapplication 2010/0016908, the entire disclosure of which is herebyincorporated herein by reference. The air pulse trains are directed tothe oral cavity by way of an oral device, which is positioned andsecured through various devices. For example, the '908 publicationdescribes, in one embodiment, an “over-the-ear” oral device configuredsuch that the flexible tubing that delivers the air pulse trains wrapsaround the ears of the user.

SUMMARY

The present invention is defined by the following claims, and nothing inthis section should be considered to be a limitation on those claims.

In one aspect, an oral device, or mouthpiece, is provided for deliveringa stimulus, for example and without limitation a fluid, to the mouth ororopharynx of a user. In one embodiment, the oral device includes threeportions: an intraoral portion, an extraoral portion, and an auxiliarysupport device. The auxiliary support device may include two ear loops(i.e., located on the right and left sides of the mouthpiece), or a bandthat surrounds the user's head, and which serve to stabilize the oraldevice. In one embodiment, the ear loops are knitted elastic. Theintraoral portion generally includes at least one outlet port throughwhich at least one agent or stimulus is delivered to the oral cavity ororopharynx. In one embodiment, the extraoral portion generally includesat least one (proximal) inlet port (or connector) that is connected to acontrol system (i.e., that generates the “agent(s)”), and at least onedistal end that is continuous with the intraoral portion of the oraldevice.

In other embodiments, the auxiliary support device may include one ormore support frames or members, including without limitation a Y-shapedyoke, a U-shaped frame, or a laterally extending support member thatengages the user's face above or at an upper lip.

In other embodiments, an oral mouthpiece includes a pair of laterallyspaced intraoral portions defining intraoral conduits each having atleast one outlet port adapted to dispense at least one fluid pulse andan extraoral portion integrally formed with each of the intraoralportions. The extraoral portions include a pair of spaced apart lipbends communicating with the intraoral portions and a pair of chinportions extending downwardly from the lip bends, with the chin portionsforming a loop positionable under the user's chin. The oral mouthpiecemay be deployed with or without an auxiliary support device.

In another aspect, a method of delivering a fluid to a predeterminedlocation in a user's mouth includes disposing a flexible tube between anouter side of a row of teeth and an inner surface of a cheek, securingthe flexible tube to the user with an auxiliary support device separatefrom the tube and formed from a different material than the flexibletube, and dispensing the fluid through the exit port.

The various oral devices and methods for the user thereof providevarious advantages. For example and without limitation, the oral devicemay be easily and securely positioned on the user in a reliable mannerwithout impinging on the face of the user, and without interfering withother accessories, such as eyeglasses or hearing aids, positioned on theuser.

The foregoing paragraphs have been provided by way of generalintroduction, and are not intended to limit the scope of the followingclaims. The various preferred embodiments, together with furtheradvantages, will be best understood by reference to the followingdetailed description taken in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described by way of example only, withreference to the accompanying drawings, in which:

FIG. 1 is a plan view of the oral mouthpiece of the present invention;

FIG. 2 is front view of a user with the oral mouthpiece of FIG. 1located in an operational position;

FIG. 3 is a plan view of an alternate embodiment of the oral mouthpieceof the present invention;

FIG. 4 is a front view of a user with the oral mouthpiece of FIG. 3located in an operational position;

FIG. 5 is a side view of the user of FIG. 4;

FIG. 6 is a plan view of an alternate embodiment of the oral mouthpieceof the present invention similar to that shown in FIG. 1 but showing aplurality of ports;

FIG. 7 is a perspective view of another embodiment of the oralmouthpiece of the present invention;

FIG. 8 is a schematic representation of the experimental protocols;

FIG. 9 is a graph showing the supply pressure versus the surfacepressure as measured at a plurality of distances form the distal tip ofthe mouthpiece;

FIG. 10 is a graph showing supply pressure versus volume delivered for 5ms pulse;

FIG. 11 is a graph showing the saliva swallowing rate;

FIG. 12 is a graph showing the effect of air-pulse train duration;

FIG. 13 is a graph showing air-pulse train duration versus sham;

FIG. 14 is a graph showing the effect of air-pulse amplitude;

FIG. 15 is a graph showing air-pulse amplitude versus sham;

FIG. 16 is a graph showing the effect of air-pulse frequency;

FIG. 17 is a graph showing air-pulse frequency versus sham; and

FIG. 18 is a histogram showing the group swallowing rates.

FIG. 19 is a plan view of an alternative embodiment oral device.

FIG. 20 is a perspective view of the yoke shown in FIG. 19.

FIG. 21 is a front view of the yoke shown in FIG. 20.

FIG. 22 is a top, perspective of the yoke shown in FIG. 20.

FIG. 23 is a side view of the yoke shown in FIG. 20.

FIG. 24 is a partial, perspective view of an alternative embodiment oraldevice.

FIG. 25 is a side view of the oral device shown in FIG. 24 applied to auser.

FIG. 26 is a front view of the oral device shown in FIG. 24 applied to auser.

FIG. 27 is a partial, perspective view of an alternative embodiment oraldevice.

FIG. 28 is a perspective view of the oral device shown in FIG. 27applied to a user.

FIG. 29 is a perspective view of an alternative embodiment of a yoke.

FIG. 30 is a partial end view of one side of the yoke shown in FIG. 29.

FIG. 31 is a perspective view of an alternative embodiment oral device.

FIG. 32 is a front, perspective view of the oral mouthpiece shown inFIG. 3.

FIG. 33 is a top view o the oral mouthpiece shown in FIG. 32.

FIG. 34 is a front view of the oral mouthpiece shown in FIG. 32 appliedto a user.

FIG. 35 is a side view of the oral mouthpiece shown in FIG. 32 appliedto a user.

FIG. 36 is an alternative to view of the oral mouthpiece shown in FIG.33.

FIG. 37 is a top view of the oral mouthpiece shown in FIG. 7.

FIG. 38 is a side view of the oral mouthpiece shown in FIG. 37 asapplied to as user.

FIG. 39 is a front view of the oral mouthpiece shown in FIG. 1 asapplied to a user.

FIG. 40 is a side view of the oral mouthpiece shown in FIG. 29 asapplied to a user.

FIG. 41 is a side view of the oral mouthpiece shown in FIG. 1 without anauxiliary support device secured thereto.

FIG. 42 is a front view of the oral mouthpiece shown in FIG. 41.

FIG. 43 is a front view of the oral mouthpiece shown in FIG. 42 with anauxiliary support device secured thereto.

FIG. 44 is a perspective view of one embodiment of an oral mouthpiece.

DETAILED DESCRIPTION OF THE DRAWINGS

Referring to FIGS. 1, 2 and 39-43, one embodiment of an oral mouthpieceis shown generally at 10. The oral mouthpiece 10 includes intraoralportions 12, extraoral portions 14 and an auxiliary support device,configured in this embodiment as ear connectors 18. The extraoralportions 14 include a supply portion 16. The intraoral portions 12define intraoral conduits. The extraoral portions 14 define an extraoralconduit. The intraoral conduit is in flow communication with theextraoral conduit.

The intraoral portion 12 of the mouthpiece 10 enters the mouth at theangle or corner of the mouth on the user's right and left sides. Theintraoral portion 12 extends along the buccal cavity, or vestibule,lateral to the teeth and medial to the cheek, on the right and leftsides of the mouth. The length of the intraoral aspect is typicallybetween 20 mm and 50 mm for human adult users, and may be less forpediatric users. The lengths of the intraoral portions may be modifiedby the user by advancing, or retracting, the intraoral segment that isin flow communication with the extraoral segment, relative to theauxiliary support device. This is an advantage of the device in that theintraoral segments may be modified to accommodate the user's specificoral anatomy. The intraoral portion or aspect 12 ends caudally with anoutput port 20 such that an agent or substance or stimulus can bedelivered from this output port 20 in the general region of theposterior mouth or oropharynx on the right and left sides.

In one embodiment, the intraoral portion 12 is oriented superiorly andcaudally within the buccal cavity such that the output port 20 issituated lateral to the maxillary premolars or molars during use. Oneadvantage of having the intraoral portion or aspect 12 angled superiorlyfrom its origin at the corner of the mouth is that the output port 20 ofthe mouthpiece does not come in contact with pooled saliva that mayaccumulate in the region of the mandibular dental arch. However, theintraoral portion 12 of the mouthpiece may be oriented along a varietyof angles, relative to the horizontal plane, providing a means forpositioning the output port 20 lateral to the mandibular molars, oralong the occlusal plane, depending upon the specific conditions andrequirements of the user including the oral anatomy and the dentition.

In another aspect, the intraoral portion 12 of the mouthpiece 10 may beoriented along a variety of angles, relative to the user's sagittalplane, and be gently curved, along this principal off-sagittalorientation, such that it follows the natural contour of the buccalcavity and maxillary or mandibular dental arches, thereby providingoptimal comfort for the user. The general orientation and localcurvature of the intraoral portion 12 can be provided as manufacturedaspects of the mouthpiece 10. Alternatively, the mouthpiece can beprovided such that these aspects of the intraoral portion 12 can bemanually molded by the clinician, caregiver, or user. The capacity toorient and curve the intraoral aspect of the mouthpiece can be providedby a length of fine malleable wire being embedded within the intraoralportion 12 of the mouthpiece on the left and right sides of the mouth.This may represent an advantage in that the user, or caregiver, would beprovided a means of molding the mouthpiece to the specific anatomy ofthe individual user.

In another aspect, the intraoral 12 and extraoral 14 portions of themouthpiece are continuous as right and left or pair of first loopedregions 22 of mouthpiece that are positioned at the right and leftangles or corners of the user's mouth during use. These two loopedregions, which form lip bends, are oriented approximately in parallelwith the user's axial or horizontal plane, at the level of the angles ofthe mouth.

The looped regions 22 where the intraoral 12 and extraoral 14 portionsof the mouthpiece meet at the angles of the mouth are contiguous with asecond, extraoral looped or curved region 24 that provides a site ofattachment or site of origin for an auxiliary support device. In otherembodiments, the looped region 24 may be omitted. In one embodiment, theauxiliary support device is configured as ear connectors 18 that areattached on the right and left sides of the mouthpiece 10. The earconnectors 18 may be ear loops that are made of a different materialthan the intraoral or extraoral portions. In one embodiment, the earloops are knitted elastic ear loops. The second looped region 24 isoriented at approximately 45 degrees relative to the sagittal plane ofthe user on the right and left sides of the mouthpiece. In use thesecond looped regions 24 sit over the face, immediately lateral to theangle of the mouth on the right and left sides, and does not extendrearwardly and/or upwardly for connection to the ears of the user.Rather, these looped regions 24 provide a point of origin for theauxiliary support device, such as the around-the-ear soft elastic earloops 18 on the right and left sides of the mouthpiece. By virtue oftheir orientation relative to the intraoral portions, these ear looporigin sites and associated ear loops provide a means of stabilizing theintraoral segments 12, without the elastic tending to pull the intraoralsegment 12 out of the mouth. These looped regions 22 and 24 arecontinuous with a communicating region that extends inferiorly from theinferior aspect of the second looped portion for approximately 30 mm to100 mm and then curves medially toward the user's midline plane so as toform a chin loop. As the right and left portions of the mouthpieceapproach the midline, they articulate with a Y-connector 26, providing ameans of delivering an agent from a single input post to right and leftintraoral aspects of the mouthpiece.

In one embodiment, the Y-connector 26 is connected to the supply portion16 of the mouthpiece 10, which supply portion continues forapproximately 90 cm. The length of the supply portion 16 may extend from0.50 meters to about 2.0 meters as shown in FIG. 44. A longer supplyportion 16 is an advantage in that the mouthpiece user may move fairlyfreely in relation to the fluid control unit. For example, themouthpiece use could move between lying and sitting in a hospital bedwith the fluid control unit mounted on the head or side rail of the bed.This feature increases the clinical utility of the mouthpiece system inthe health care and home settings. At the end of the supply portiontube, a male luer connector may be provided. Alternatively, a lowpressure one-way check valve luer connector 17 is provided. This is toprevent contamination of the control unit by any fluids, bodily orotherwise, that may traverse the tubing 16. The check valve 17 mayreduce the flow into the mouthpiece, dropping the flow rate to 2.4 to2.5 L/min. The flow may be maintained above 2.0 L/min. The frequency andamplitude are not affected by the inclusion of the check valve 17.

A control unit 28 is connected to the distal end of the supply portion16 of the mouthpiece 10. The control unit 28 generates at least oneagent, or delivers at least one agent to the supply portion 16 of themouthpiece 10. Preferably the Y-connector is adjustable so that it canextend past the cheek/jaw thereby minimizing a patient's tendency todislodge the mouthpiece. However, there may be instances when a longerportion 14 is desirable, for example, in patients who are very sensitiveto contact about the face and mouth.

In another embodiment shown in FIGS. 3-5 and 32-36, a continuous chinloop or region 30 is provided, extending from the right elasticattachment loop 24 (shown in FIGS. 3 to 5) and, running inferiorly tothe level of the user's chin, crossing the midline immediately anteriorto the chin, and extending to the other side of the face where it runssuperiorly and continues as the left elastic attachment loop 24 as bestseen in FIGS. 4 and 32.

In another aspect, one embodiment of the auxiliary support device isconfigured as ear loops 18 attached to the second looped 24 aspect ofthe extraoral portion 14 of the mouthpiece 10, described above. In oneembodiment, the ear loops 18 are made of knitted nylon polyester elasticand are between 4 cm and 25 cm in length and between 1 mm and 7 mm inwidth. The ear loops 18 originate from a single site on the secondcurved portion 24 of the mouthpiece 10. There are several advantagesafforded by the ear loops 24. In one embodiment, the auxiliary supportdevice, and in particular the ear loops or head band, are more compliantor flexible (less stiff) than the extraoral and/or intraoral portions.For example, the ear loops or head band may have a much lower modulus ofelasticity than the intraoral and extraoral portions, made for exampleof thermoformed tubing. The ear loops or head band provide a means ofstablilizing the mouthpiece during use. Being made of soft, knittedelastic material such as nylon polyester, the ear loops stretchsubstantially such that the mouthpiece can be effectively andcomfortably stabilized and worn by individuals with different cranialand facial anatomy. The soft knitted material reduces the likelihoodthat the mouthpiece will cause discomfort or tissue damage to the hairyskin of the face or pinna. The narrow width and malleability/flexibilityof the knitted elastic ear loops is another advantage in that the earloops do not interfere with over-the-ear hearing aids or theover-the-ear portion of eyeglasses. This is particularly important sinceusers of the mouthpiece will include older adults, as well as pediatricusers who require eyeglasses and hearing aids as the result ofcongenital syndromes or conditions. The soft, knitted ear loops provideuser comfort, even when the mouthpiece is used for extended periods oftime.

In use, some flexibility at points 20, 22, and 24 provide a means ofimproving the fit, efficacy, and comfort of the mouthpiece for faces ofvarious shapes and sizes. Some degree of malleability in the chin piece30 (shown in FIGS. 3 to 5) and extraoral portions 14 (shown in FIGS. 1and 2) is also advantageous in that this allows improved positioning ofthe two sections that rise up toward the angles of the mouth.

Another advantage of the knitted ear loops 18 is that many users,caregivers, and clinicians are familiar with them based on previousexperience with ear loops on medical masks. Thus, the ear loops 18 willfacilitate easy positioning of the mouthpiece by users by virtue oftheir general familiarity with the procedures around knitted ear loops.Even for users who have not previously used knitted ear loops, there isan intuitive element around ear loops that would increase the likelihoodthat a naive user would position them correctly around the ears.

The mouthpiece 10 may be made of flexible tubing, for example, a pair offlexible tubes configured to be positioned on opposite sides of the faceof a user. The oral device may include only a single tube positioned onone side of the user's face, for example, for the purpose of deliveringan agent to one side of the mouth or oropharynx. This may beadvantageous, for example, in patients who have undergone unilateralsurgery for oral cancer, or in the case of a unilateral sensorimotorimpairment of the face, mouth, or oropharynx.

The flexible tubes may be made of tubing which can be shaped into agiven configuration but which has some flexibility and ability toconform to the face and mouth of the user. The tubes may have a ⅛th inchouter diameter and a 1/16th inner diameter forming a lumen. In variousembodiments, the intraoral and/or extraoral portions may be made ofvarious materials, including without limitation, polyurethane,polyethylene, PVC, silicone, rubber, or other suitable and biocompatiblematerials, and/or combinations thereof. In one embodiment, the tubing is1.6 mm ID×3.2 mm OD tubing made of TYGON® MPF-100 available fromSaint-Gobain, Akron, Ohio.

It will be appreciated by those skilled in the art that the intraoralportions 12 may have a plurality of ports 40 formed therein in additionto the ports 20 positioned at the distal end of the intraoral portions12.

Referring to FIGS. 7, 37 and 38, the oral device 50 shown herein andfully described in US 2010/0016908 and WO 2009/127947, both of which arehereby incorporated herein by reference, may be improved upon by addingan auxiliary support device, shown as ear loops 52. Ear loops 52 aresimilar to those described above but are attached to the extraoralportion 54 proximate to where the extraoral portion 54 meets theintraoral portion 56. While the ear loops 52 serve to secure the oraldevice 50 to a user in a secure fashion. In the absence of earloops,this embodiment has the shortcoming that it can move out of positionwhen the subject opens his/her mouth, or in patients with mouth/lipweakness the mouthpiece 50 could move out of position during use.

Referring to FIGS. 19-23, 29-30 and 44, another embodiment of an oraldevice is shown. The oral device includes a pair of laterally spacedintraoral portions 112 defining intraoral conduits each having at leastone outlet port 120 adapted to dispense at least one fluid pulse. Anextraoral portion 114 is integrally formed with each of the intraoralportions. The extraoral portions define extraoral conduits in flowcommunication with the intraoral conduits. An auxiliary support deviceincludes a yoke. In one embodiment, the yoke is configured as a Y-shapedframe 132 having a pair of arm portions 134 and an inlet portion 136,each configured with grooves or channels in which the extraoral portionsare disposed and secured. As shown in FIG. 23, the arm portions curverearwardly from the inlet portion. In one embodiment, the arm portionsextend at an angle α of about 20-60 degrees, and in one embodiment at anangle α of about 30-45 degrees, and in one embodiment at an angle α of38.5 degrees. The frame shapes and holds the extraoral portions. Inaddition, each of the pair of arm portions 134 includes a wing with anattachment member 140. At least one securing member 142, configured forexample and without limitation as an elastic band, may be secured to theattachment members 140. The band may be configured as a pair of earloops, or as a single headband that encircles the user's head andlocates and holds the yoke in position.

Referring to FIGS. 29 and 30, in one embodiment, wing portions 440 havea concave curved portion 444 that interfaces with the lips, or corner ofthe user's mouth, with the end portions 442 of the yoke arms extendinginto, and positioning intraoral portions of the tubing, in the mouth ofthe user. In essence, the end portions 442 and the attachment member 140have a recess 446 formed therebetween so as to locate the yoke relativeto the user, and the lips/mouth in particular, with the force applied bythe securing member 18 urging the yoke against the user's lips/mouth.Referring to FIG. 30, the width (W) of the wing 440 may be widened atthe junction 448 of the end portions 442 and the wings 440 at the areaof contact with the user's lips/mouth so as to reduce the tissue contactpressure.

Referring to FIGS. 24-26, another embodiment of the oral device includesa pair of tubes 200, each defining intraoral and extraoral portions, andwhich may be configured as substantially straight, flexible tubes, ormay include lip bends as described above. A laterally extending supportmember 230 extends transversely to the tubes 200 and is positioned abovean extraoral portion 214. The support member 230 may engage the user'sface above or on/at an upper lip thereof. The support member 230 may bemade of a cloth-like material, and may be elastic or non-elastic. Thesupport member is coupled to the tubes 200 with a pair of clips 232. Theclips 232 may be wrapped around the tubes, and are secured to thesupport member with fasteners, adhesives or combinations thereof. Theclips 232 may include a lip bend portion that wraps around the upper lipof the user. At least one securing member 242 is coupled to oppositeends of the support member. The securing member may be configured as apair of ear loops, or as a single head band. In use, the intraoralportions 212 are disposed in the user's mouth, with the support member230 supported by the user's upper lip and securely held thereto with thesecuring member 242. This device may be particularly well suited forindividuals that may have particular ailments or sensitivities aroundand under the chin.

Referring to FIGS. 27 and 28, another embodiment of an auxiliary supportdevice includes a U-shaped frame 330 shaped and configured to bepositioned under the user's chin. The frame has opposite end portions332 coupled to an extraoral portion 314, and at least one securingmember 342 coupled to the opposite end portions 332. For example, thetubes making up the extraoral portions may extend through openings 344formed in the end portions. The U-shaped frame may be made from aflexible, but semi-rigid material, such as a plastic strip. Theextraoral portions 314 may include ear loop portions 316, therebyforming an integral securing member, or may extend downwardly along thechin as shown for example in the embodiment of FIG. 1. At least onesecuring member 342, configured as individual ear loops or as a headband may be additionally secured to the end portions, or may be the solesupport for the end portions. The securing member locates and holds thesupport device firmly in position.

Referring to FIG. 31, another embodiment of an oral device 500 includesa pair of downwardly extending extraoral inlet portions 502, eachconfigured with an attachment member 504, or loop, that may be coupledto a securing member, such as an ear loop or head band. The inletportions have an opening 508 shaped and dimensioned to receive anauxiliary extraoral tube 506. The oral device further includesintegrally formed intraoral portions 510, which are shaped and contouredto be positioned in the vestibule of the user's mouth between the teethand inner cheek/lips. The intraoral portions are in fluid communicationwith the extraoral inlet portions, and thereby with the tubes 506positioned in the inlet portions. The ends of the intraoral portions areeach configured with a fluid exit port 512. An intraoral bridge 514extends between the opposing pairs of inlet portions/intraoral portions.The bridge 514 is curved and shaped/dimensioned to be positioned in thevestibule. A cutout 516, or clearance opening, is formed in amid/intermediate portion of the bridge to provide clearance for themaxillary labial frenulum. In one embodiment, the intraoral portions andbridge 510, 514 are positioned between the upper teeth and the user'scheek, with the inlet portions 502 extending downwardly. In anotherembodiment, the intraoral portions are positioned between the lowerteeth and cheeks, with the inlet portions extending upwardly. A securingmember 18, e.g., ear loops or head band, is coupled to the attachmentmembers and secures the oral device to the user. The oral device may bemade of a molded rubber compound, or of various polymers otherwiseherein described.

In any of the embodiments, a wire may run along a length of at least aportion of the flexible tubing forming either or both of the intraoraland extraoral portions. The wire provides further shape memory to theflexible tubing. For example, the oral devices disclosed herein may beshaped by inserting a length of fine wire into the tubing and thenbending the wire.

There are a number of advantages realized with the different embodimentsof the oral mouthpiece of the present invention. Specifically themouthpiece is stabilized during use by the user by the auxiliary supportdevices, including for example and without limitation the soft elasticloops that fit around the ears. This advantage provides a means ofmaintaining the intraoral aspects of the mouthpiece in appropriateposition, even when the lips are open (as in the case of a patient withlip weakness), during talking, and during other behaviours such asyawning, eating, chewing, and drinking from a glass or straw.Importantly, this feature of the mouthpiece prevents the intraoralportions of the mouthpiece from migrating toward the pharynx, or inother directions, during use by a person, thus enhancing the safetyaspect of the device.

Use of the auxiliary support devices stabilizes the mouthpiece so as toreduce the likelihood that the stabilization component of the mouthpiecewill be perceived as irritating by the user and cause tissue damage withprolonged use.

The head band and soft, elastic ear loops are intuitive in terms ofpositioning, since they are used in other devices with which the userhas likely had previous experience, for example, a medical face mask.The head band and soft elastic ear loops are straightforward tomanipulate, thereby facilitating correct positioning by patients. Theelastic bands are also narrow, occupying very little area over andaround the pinna of the ear or rear of the skull, thus allowing easypositioning and use by persons who wear glasses or over-the-ear hearingaids.

In the various embodiments, there is no mouthpiece material occupyingthe midline region of the mouth. Rather, the intraoral portions of themouthpiece enter the mouth as the angles of the mouth on the left andright sides, leaving the midline oral region free to engage in talking,eating, drinking, and other oral behaviours, and providing a situationin which the appearance of the mouthpiece is considered more sociallyappropriate than with devices that occupy the midline oral region. Ofcourse, it should be understood that the conduit may extend along themidline of the chin, and then diverge to the left and right sides of themouth.

The tubing comprising the mouthpiece is molded such that the left andright intraoral portions extend outside the mouth at the angles as anextraoral portion that is continuous between the right and left sides,and that extends inferiorly to run laterally at the level of the chin.An important advantage of this aspect of the mouthpiece is that itprevents the mouthpiece from being swallowed. In one embodiment, thisextraoral portion of the mouthpiece can be used to further tether themouthpiece, or to attach other devices.

The mouthpiece is relatively small and light-weight. In one preferredembodiment, it is envisaged that the mouthpiece can be readilymanufactured at minimal cost, given the simplicity of the design, thesmall length of tubing required, and the low costs of the other requiredmaterials such as the elastic.

The mouthpiece can be easily connected to the output of an air-pressureregulator through a length of tubing that extends from the extraoralportion of the mouthpiece in the region of the mandible.

The mouthpiece comes manufactured with a looped configuration, orientedon the horizontal plane that fits around the angle of the mouth. Thisaspect of the tubing is contiguous with a second loop that is situatedextraorally, immediately lateral to the angle of the mouth and orientedapproximately 45 degrees relative to the user's midsagittal plane. Thesoft elastic ear loops originate at this second looped region and extendover and around the pinna of the ears. With this design, the elastic earloops do not pull directly on the intraoral portions of the mouthpiece,causing them to migrate. Rather, the elastic ear loops pull on thesecond looped area (described above) with the result that the intraoralportions of the mouthpiece remain stable during use.

The mouthpiece can provide an attachment platform for other oraldevice(s), or oral device components.

The mouthpiece can be used as an oral suction catheter.

The intraoral portions of the mouthpiece can be provided as coloredelements, providing a cue to the user regarding the portion of thedevice that is to be inserted into the mouth; by coloring the twointraoral and/or extraoral segments different colors, and providingassociated written instructions (e.g., green=right, red=left), themouthpiece provides increased assurance that the mouthpiece will bepositioned accurately and not positioned upside down. “Right” and “left”icons can also be provided, as well as “finger icons” showing thepositions where the fingers should be placed during placement.

The user can close the lips while the mouthpiece is in position,allowing the user to maintain a typical facial rest position during use.

Importantly, there is no mouthpiece material disposed between thecontacting surfaces of the upper and lower teeth. This is advantageoussince a significant distance between the upper and lower teeth mayreduce the user's ability to swallow with the device in position.

There is no material between the superior surface of the tongue, and thepalate. This is also an advantage in terms of swallowing sinceswallowing requires approximation of the superior tongue surface and thepalate to transport ingested material from the mouth to the pharynx.

The mouthpiece can be provided with a flavored element within theintraoral portion, on the surface of the intraoral portion, or on orwithin the extraoral portion that runs outwardly between the user'supper and lower lips. This flavoring may increase the acceptability ofthe mouthpiece, as well as promote salivary flow, and swallowing.

The mouthpiece is small and portable. It can be fit into a purse orsmall carrying bag, or into a typical “sandwich baggie” for easy andclean transport.

The agent(s) delivered to the mouth and oropharynx via the mouthpiecedescribed herein may include, but are not limited to, a fluid, includinga gas or liquid. For example, air may be delivered to the posterior oralcavity and oropharynx via the mouthpiece. In this regard, our previousstudies, as well as those from other laboratories, have shown thatapplication of air-pulse trains to the oropharynx increases salivaswallowing rates in young and older adults, and activates regions of thehuman cerebral cortex. Tests were undertaken to determine the effects oforopharyngeal air-pulse: train duration, amplitude, and frequency onsaliva swallowing rates in dysphagic stroke and to determine salivaswallowing rates associated with air-pulse application different fromswallowing rates associated with a sham condition, in dysphagic stroke.

In the first of two experiments, twenty three (23) hospitalizedindividuals who had dysphagia secondary to a stroke volunteered assubjects. Their median age was 69, and 15 were male. The majority hadsuffered a stroke involving the right middle cerebral artery territory,however other stroke locations were also represented in the sample. Themedian days post-stroke at the time of testing was 12 days. Studyenrolment was limited to patients who were dependent on tube feeding tosome degree; thus, the median FOIS score for the sample was 1.5, with arange of 1 to 3. The experimental protocol is shown in FIG. 8.

Air-pulse trains were delivered bilaterally to the posterior oral cavityand oropharynx via a prototype buccal mouthpiece which was positionedbetween the subject's upper teeth and the cheek.

The air-pulse trains were controlled with an Agilent signal generatorand LABneb air-pressure regulator, attached to a hospital wall-mountedcompressed medical air source. We examined 4 levels of air-pulse trainduration: a single pulse, a doublet or two successive pulses, a 2 secondtrain, and a 3 second train; 4 levels of air-pulse amplitude weredefined in terms of supply pressures of 2, 4, 6, and 8 psi; and finally,4 levels of pulse frequency, 2, 4, 8, and 12 Hz, were examined. Based onbench testing, this range of supply pressures corresponded to tippressures, measured 2 mm to 8 mm from the distal tip of the mouthpiece,of no greater than 2 mm Hg, as shown in FIG. 9.

The air volume delivered with a single pulse in this supply pressurerange was 1.2 ml to 4.2 ml, as shown by the tables provided below andthe graph of FIG. 10.

Volume Collected [mL] SINGLE Source Pressure [psi] 50 ms 0 2 4 6 8 12 1Hz 0 1.2 2.3 3.1 4.2 5.8 0 1.3 2.3 3.2 4.4 6.1 0 1.2 2.2 3.2 3.9 6 Mean0.00 1.23 2.27 3.17 4.17 5.97 SD 0.00 0.06 0.06 0.06 0.25 0.15 VolumeCollected [mL] 2 PSI 4 PSI 6 PSI 8 PSI 2 Sec 2 Hz 3.8 7.5 12.1 15.6 47.4 11.8 15.8 4.2 7.7 11.9 15.5 Mean 4.00 7.53 11.93 15.63 SD 0.20 0.150.15 0.15 4 Hz 6 14.4 23.5 31.4 6 15.1 23.7 31.6 6.1 14.5 23.4 30.8 Mean6.03 14.67 23.53 31.27 SD 0.06 0.38 0.15 0.42 6 Hz 12 25.1 36.4 45 11.825.2 36.3 47 11.6 24.8 36 48 Mean 11.80 25.03 36.23 46.67 SD 0.20 0.210.21 1.53 8 Hz 14 32.4 50 62 14.1 32.7 49 62 13.7 32.8 50 62 Mean 13.9332.63 49.67 62.00 SD 0.21 0.21 0.58 0.00 12 Hz 20.6 44 68 90 20.4 46 6889 20.7 46 68 90 Mean 20.57 45.33 68.00 89.67 SD 0.15 1.15 0.00 0.58 3Sec 2 Hz 5 12 22 26 4 12 22 28 4 12 22 27 Mean 4.33 12.00 22.00 27.00 SD0.58 0.00 0.00 1.00 4 Hz 8 28 38 48 8 27 38 50 8 29 36 50 Mean 8.0028.00 37.33 49.33 SD 0.00 1.00 1.15 1.15 6 Hz 14 36 54 70 18 38 54 70 1638 55 68 Mean 16.00 37.33 54.33 69.33 SD 2.00 1.15 0.58 1.15 8 Hz 20 4470 90 22 46 72 92 24 46 72 90 Mean 22.00 45.33 71.33 90.67 SD 2.00 1.151.15 1.15 12 Hz 30 62 92 130 28 62 92 130 29 60 94 130 Mean 29.00 61.3392.67 130.00 SD 1.00 1.15 1.15 0.00

Pulse duration was 50 msec throughout.

Air pulse types were presented in blocks of train duration and shamconditions, that is, there were a total of 5 blocks: single pulse,doublet, 2-sec pulse train, 3-sec pulse train, and sham, two of whichare shown here. Successive duration blocks were separated by a 1 minbaseline period.

Their order was randomized across subjects. The four air-pulse amplitudeconditions were nested as blocks within train duration; and the fourlevels of air-pulse frequency were further nested within amplitudeblocks. There were two orders of each of the amplitude and frequencyconditions across subjects. The duration between the onsets ofsuccessive pulse trains was approximately 20 sec.

During the sham condition, the air pressure regulator was turned to “0”but the signal generator operated such that the subjects, andexperimenters, heard the same noise of the solenoids during theair-pulse and sham conditions.

Dry swallows were identified from the output signals of a Grass throatmicrophone, a laryngeal movement sensor, and respiratory movementsensor. Two swallows are shown here in relation to three singleair-pulse trials. One experimenter observed the subject throughout thesession and marked the computer file for swallows and other behaviors.Swallowing rates were computed as number of swallows over duration ofthe air-pulse condition, from the onset of 1 trial to the onset of thefollowing trial.

A repeated measures 1-way ANOVA indicated that there was a main effectof Train Duration on saliva swallowing rate (p<0.05). Post-hoccomparisons, with Bonferroni correction, indicated that mean swallowingrates associated with the 2 sec, and the 3 sec train duration conditionswere significantly greater than the mean swallowing rate associated withthe single pulse condition (p<0.008) as shown in FIG. 11.

In relation to the sham condition, paired t-tests, again Bonferronicorrected, indicated that the mean swallowing rate associated with the 2sec train duration condition was significantly greater than theswallowing rate associated with the sham condition (p<0.013) as shown inFIGS. 12 and 13.

Turning now to air-pulse amplitude, there was no main effect ofair-pulse AMPLITUDE on dry swallowing rate. Compared with the SHAMcondition, the 6 psi condition approached the corrected significancelevel of 0.013 (p=0.015). And, the average swallowing rate across the 4levels of amplitude was significantly greater than the mean swallowingrate associated with the SHAM condition (p<0.05) as shown in FIGS. 14and 15.

Looking now at air-pulse frequency, there was no mean effect ofair-pulse FREQUENCY on dry swallowing rate. Compared with the SHAMcondition, the 12 Hz condition approached the corrected significancelevel (p=0.018). The average swallowing rate across the 4 levels ofair-pulse frequency was significantly greater than the mean swallowingrate associated with the SHAM condition (p<0.05) as shown in FIGS. 16and 17.

For the air-pulse Duration, Amplitude and Frequency conditions examined,there was considerable variability in dry swallowing rates, asillustrated by the large standard deviations.

In summary, it was determined that swallowing rates showed substantialvariability for the air-pulse types examined. Longer air-pulse trainswere associated with greater swallowing rates compared with singlepulses; swallowing rates associated with 2 sec air-pulse trains weresignificantly greater than sham. While swallowing rates were notsignificantly different as a function of air-pulse (i) amplitude, and(ii) frequency conditions, swallowing rates pooled across amplitude orfrequency levels were significantly greater than sham. Air-pulse trains,delivered to the posterior mouth and oropharynx via a buccal mouthpiece,were associated with increased saliva swallowing rates in dysphagicstroke.

Dry swallowing rates are influenced by the specific properties ofair-pulse trains delivered to the posterior mouth and oropharynx indysphagia stroke. Air-pulse application is associated with increased dryswallowing rates in dysphagic stroke, supporting the potential of theair-pulse approach in swallowing rehabilitation.

Although there were some significant effects of the air-pulse parametersunder study, the effects of air-pulse frequency and amplitude were notmarked. With regards to pulse-train duration, the 2-second pulse trainappears to be superior to the other pulse types in terms of facilitatingswallowing in patients with dysphagia. However, even in the case ofduration, there was not a single setting that proved to be categoricallysuperior to the others in terms of associated swallowing rates. Thissuggests that air pulses that fall within a range of pulse types can beassociated with increased swallowing in patients with swallowingimpairment. This is an advantage of the air-pulse approach in that thephenomenon does not appear to be limited to a very narrow set of pulsetypes.

The present finding that air-pulse amplitude and frequency did not havemore pronounced effects on swallowing rates suggests the possibilitythat factors other than air pressure may be important in determining theswallowing response.

Based on this study, air-pulse trains of 2 sec appear to be particularlyeffective in evoking swallowing in patients with dysphagia followingbrain injury. Air-pulse trains involving a supply pressure of 6 psi, andinvolving a frequency of 12 Hz, i.e., involving flow values in the rangeof 68 mls, also appear to be particularly effective, based on thecurrent testing results in dysphagic patients.

This study demonstrates that oropharyngeal air-pulse trains deliveredvia a buccal mouthpiece and involving tip pressures (i.e., measured at 2mm to 8 mm from the tip through bench testing) of less than or equal to2 mm Hg are effective in increasing saliva swallowing rates in patientswith dysphgia following stroke.

The subjects in the current study participated in testing sessions thatwere approximately 75 minutes in duration. During that period, air-pulsetrains were delivered for a period of approximately 20 minutes in 6minute blocks based on air-pulse train duration, the order of which wasrandomized across subjects. Subjects were observed to swallow during thevarious air-pulse duration blocks. There was no trend for swallowing todecrease over the course of the testing session. Based on thisexperience, an air-pulse application period of approximately 20 minutesis appropriate and preferred in terms of increasing swallowing rates inpatients with dysphgia following stroke.

The time between successive air-pulse trains should be (i) short enoughthat the patient receives an adequate number of bursts per session, but(ii) long enough that the patient does not risk desaturation because ofan excessive number of swallowing apneas. Based on the experimentdescribed above, preferred air pulse trains of bursts of 2 sec, 6 psiand 12 Hz, and an inter-stimulus time of 20 sec, the mean+1 sdswallowing rate is less that 3 per min.

Therefore, even patients who respond quite well to the air pulses wouldnot be expected to swallow more than 3 times per minute with aninterburst time of 20 sec. A swallowing rate of 3 per min is less thantypical swallowing rates for cup drinking, or mealtime eating. Based onthis logic, a 20 sec period between the onsets of successive air-pulsetrains may be appropriate and thus preferred.

Based on our finding that air-pulse trains of 12 Hz are particularlyeffective, as well as our hypotheses on air flow, a second study wasdesigned to examine higher frequencies, and different air flows, asfollows:

Oropharyngeal air pulses in the 2 to 12 Hz range are associated withincreased swallowing rates in controls and dysphagic patients. However,the effects of higher frequency air pulses, and air flow, are unknown.Therefore, the effects of oropharyngeal air-pulse frequency, and airflow on dry swallowing rates in healthy adults was examined, andcompared with a lower frequency air-pulse train employed previously.Methods: Air-pulse trains (duration=3 sec) were delivered to theoropharynx via a prototype buccal over-the-ear mouthpiece in 25 adults(mean±sd age: 26.7±7.9 years; 18 female). Laryngeal, respiratory, andacoustic signals were recorded while six air-pulse conditions wererandomly administered to each subject: three Frequency conditions (i.e.,26 Hz, 40 Hz, 59 Hz); crossed with two Flow conditions (i.e., Low AirFlow, High Air Flow) as shown in FIG. 18. A Sham condition, and an 8 Hzair-pulse train previously associated with swallowing, were alsoexamined. Results: While main effects of Frequency, Air Flow, and theFrequency×Air-Flow interaction were not statistically significant(Repeated Measures 2-way ANOVA, pcrit<0.05), Air Flow approachedsignificance (pobs=0.056). When the data were averaged across Frequencyconditions, the mean swallowing rate during the 8 Hz condition wassignificantly greater than that during the Low Flow condition; however,the 8 Hz and High Flow conditions were not significantly different(paired t-test, pcrit<0.025). Moreover, swallowing rates during the HighFlow and 8 Hz conditions were significantly greater than the Shamswallowing rate, whereas the Low Flow and Sham conditions were notsignificantly different (paired t-test, pcrit<0.016). Conclusion:Oropharyngeal air-pulse trains delivered across a range of frequencies,particularly at higher air flows, increase dry swallowing rates inhealthy adults, supporting their potential in dysphagia rehabilitation.

In addition to increased dry swallowing during the air-pulse applicationperiods, some subjects were observed to display increased overallarousal, and increased overall motor behaviour, in relation to theair-pulse application. For example, some patients opened their eyes,moved their arms and legs, changed position in their chair, etc, inrelation to the air-pulse application. Based on the observation,air-pulse application to the back of the mouth and/or the oropharynxappears to provide a method on increasing overall arousal in individualswith brain damage, and further appears to provide a method of increasingmotor behaviour in individuals with brain damage. These methods areparticularly important in patients with brain damage, for example, instroke, where decreased arousal and lack of motor behaviour can besignificant challenges during the stroke recovery period that may limitgains in rehabilitation. Thus, the air-pulse approach may be employed inthe rehabilitation of patients with brain injury, or possibly dementia,to increase arousal and motor behaviour, in addition to increasingswallowing.

The increased arousal and motor behaviour observed in patients withstroke in association with air-pulse application to the posterior mouthand oropharynx in consistent with our previous finding thatoropharyngeal air-pulse application activates the cerebral cortex inhealthy control subjects. Various aspects of those findings are furtherdisclosed in U.S. Publication No. 2010/0010400A1, entitled Method ofBrain Activation, the entire disclosure of which is hereby incorporatedherein by reference. Therefore, for example, cortical activationsecondary to air-pulse application may mediate the increases in arousaland motor behaviour observed among stroke patients in the current study.

Generally speaking, the systems described herein are directed to oralmouthpieces. As required, embodiments of the present invention aredisclosed herein. However, the disclosed embodiments are merelyexemplary, and it should be understood that the invention may beembodied in many various and alternative forms. The Figures are not toscale and some features may be exaggerated or minimized to show detailsof particular elements while related elements may have been eliminatedto prevent obscuring novel aspects. Therefore, specific structural andfunctional details disclosed herein are not to be interpreted aslimiting but merely as a basis for the claims and as a representativebasis for teaching one skilled in the art to variously employ thepresent invention. For purposes of teaching and not limitation, theillustrated embodiments are directed to oral mouthpieces.

As used herein, the terms “comprises” and “comprising” are to construedas being inclusive and open ended rather than exclusive. Specifically,when used in this specification including the claims, the terms“comprises” and “comprising” and variations thereof mean that thespecified features, steps or components are included. The terms are notto be interpreted to exclude the presence of other features, steps orcomponents.

What is claimed is:
 1. An oral mouthpiece comprising: a pair oflaterally spaced intraoral portions defining intraoral conduits eachhaving at least one outlet port adapted to dispense at least one fluidpulse; an extraoral portion integrally formed with each of the intraoralportions, the extraoral portions defining extraoral conduits in flowcommunication with the intraoral conduits, the extraoral portions beingconnectable to a fluid supply wherein the intraoral portions andextraoral portions form a delivery conduit; and an auxiliary supportdevice comprising a yoke, wherein the yoke comprises a Y-shaped framesupporting the extraoral portions, wherein the Y-shaped frame comprisesan inlet portion lying in a first plane and a pair of arm portions lyingin a second plane and extending laterally outwardly in oppositedirections from the inlet portion, wherein the arm portions extendrearwardly from the inlet portion in a same rearward direction, andwherein the second plane forms an angle of between about 20-60 degreesrelative to the first plane.
 2. The oral mouthpiece of claim 1 furthercomprising a pair of attachment members positioned on opposite sides ofthe Y-shaped frame, and at least one securing member connected to theattachment members.
 3. The oral mouthpiece of claim 2 wherein the atleast one securing member comprises an elastic band.
 4. The oralmouthpiece of claim 2 wherein the attachment members each comprise awing portion.
 5. The oral mouthpiece of claim 3 wherein the wingportions each comprise a concave curved portion adapted to interfacewith the user.
 6. The oral mouthpiece of claim 3 wherein the armportions have end portions spaced from the wing portions.
 7. The oralmouthpiece of claim 2 wherein the securing member comprises an elasticband.
 8. The oral mouthpiece of claim 1 wherein the extraoral portionsmeet in an adjustable Y-connector below the Y-shape frame.
 9. The oralmouthpiece of claim 1 wherein each of the intraoral portions extendsfrom a centre to each side of a user's mouth.
 10. The oral mouthpiece ofclaim 1 where each of the intraoral portions includes a plurality ofexit ports.
 11. The oral mouthpiece of claim 1 wherein said Y-shapedframe comprises channels formed in the inlet and arm portions, whereinthe extraoral portions are disposed in the channels.
 12. The oralmouthpiece of claim 1 wherein the second plane forms an angle of betweenabout 30-45 degrees relative to the first plane.
 13. The oral mouthpieceof claim 12 wherein the second plane forms an angle of about 38.5degrees relative to the first plane.
 14. The oral mouthpiece of claim 1wherein the intraoral portions extend outwardly from ends of the armportions.
 15. The oral mouthpiece of claim 1 wherein the intraoral andextraoral portions are formed from a single tube.
 16. An oral mouthpiececomprising: a pair of tubes each defining in part an intraoral conduithaving at least one outlet port adapted to dispense at least one fluidpulse and an extraoral conduit integrally formed and in flowcommunication with each of the intraoral conduits, the extraoralconduits being connectable to a fluid supply wherein the intraoralconduits and extraoral conduits form a delivery conduit; and a Y-shapedframe supporting at least the extraoral conduits, the Y-shaped framecomprising an inlet portion lying in a first plane and a pair of armportions lying in a second plane and extending laterally outwardly inopposite directions from the inlet portion, wherein the arm portionsextend rearwardly from the inlet portion in a same rearward direction,and wherein the second plane forms an angle of between about 20-60degrees relative to the first plane.
 17. The oral mouthpiece of claim 16further comprising a pair of attachment members positioned on oppositesides of the Y-shaped frame, and at least one securing member connectedto the attachment members.
 18. The oral mouthpiece of claim 17 whereinthe attachment members each comprise a wing portion.
 19. The oralmouthpiece of claim 18 wherein the wing portions each comprise a concavecurved portion adapted to interface with the user.
 20. The oralmouthpiece of claim 18 wherein the arm portions have end portions spacedfrom the wing portions.
 21. The oral mouthpiece of claim 17 wherein thesecuring member comprises an elastic band.
 22. The oral mouthpiece ofclaim 16 wherein the extraoral conduits meet in an adjustableY-connector below the Y-shape frame.
 23. The oral mouthpiece of claim 16where each of the intraoral portions includes a plurality of exit ports.24. The oral mouthpiece of claim 16 wherein the second plane forms anangle of between about 30-45 degrees relative to the first plane. 25.The oral mouthpiece of claim 24 wherein the second plane forms armportions form an angle of about 38.5 degrees relative to the firstplane.